Highest risk U.S. Food and Drug Administration

Bryant Ranch Prepack Morphine Sulfate 30 mg Extended-Release tablets recall: Incorrect labeling

Recall published 4+ years ago

Incorrect labeling

Bryant Ranch Prepack Prescription & OTC drugs — recalled prescription & otc drugsBryant Ranch Prepack Prescription & OTC drugs — recalled prescription & otc drugs (photo 2)Bryant Ranch Prepack Prescription & OTC drugs — recalled prescription & otc drugs (photo 3)Bryant Ranch Prepack Prescription & OTC drugs — recalled prescription & otc drugs (photo 4)
4 photos published by U.S. Food and Drug Administration with the recall notice.

The hazard: Mislabelling or misbranding

Misbranding prompted this recall. The agency treats a label that misstates the contents as seriously as it treats contamination, because people act on labels.

What the notice says: Risk Statement: Patients prescribed the 30 mg dose who receive the 60 mg dose could be at risk for overdose and death.

Why it matters: The product carries the wrong label, the wrong lid or the wrong packaging. The food inside is generally fine; the problem is that the package describes something else, which defeats anyone relying on it.

Symptoms and when to call a doctor

There is no illness associated with mislabelling itself. The exception is where the undeclared contents include an allergen, in which case treat it as an allergen recall and watch for the reaction that person normally has.

This page is general information, not medical advice. If you feel unwell, a clinician who can see you is the only person able to judge your case.

Recall details

Published
June 28, 2022
Risk level
Highest risk
Issued by
U.S. Food and Drug Administration
Brand
Bryant Ranch Prepack
Product type
Prescription & OTC drugs

Products covered by this recall

Morphine Sulfate 30 mg Extended-Release tablets

What the company announced

06/28/2022 – Burbank, California, Bryant Ranch Prepack Inc. is voluntarily recalling one lot of Morphine Sulfate 30 mg Extended-Release tablets (Comprised of 10 bottles), and one lot of Morphine Sulfate 60 mg Extended-Release tablets (Comprised of 10 bottles) to the consumer level listed in the table below. The products have been found to have incorrect labeling where bottles labeled as Morphine Sulfate 60 mg Extended-Release tablets contain Morphine Sulfate 30 mg Extended-Release tablets and bottles labeled as Morphine Sulfate 30 mg Extended-Release tablets may contain Morphine Sulfate 60 mg Extended-Release tablets.

Risk Statement: Patients prescribed the 30 mg dose who receive the 60 mg dose could be at risk for overdose and death. Patients prescribed the 60 mg dose who receive the 30 mg dose may experience withdrawal and untreated pain if the dose given is too low. To date, Bryant Ranch Prepack Inc. has not received any reports of adverse events related to this recall.

  • Product: Morphine Sulfate Extended-Release Tablets · Strength: 30 mg · Quantity per bottle: 100 · NDC: 63629-1088-01 · Lot: 179642 · Expiration: 11/30/2023
  • Product: 60 mg · Strength: 100 · Quantity per bottle: 63629-1089-01 · NDC: 179643 · Lot: 08/31/2023

Morphine Sulfate Extended-Release tablets are used to manage severe pain. The 30 mg tablets are round, purple-colored, film-coated tablets debossed with "RD" and "71" on one side and plain on the other side. The 60 mg tablets are round, light orange-colored, film-coated tablets debossed with "RD" and "72" on one side and plain on the other side.

Bryant Ranch Prepack is notifying its distributors and customers by email, phone, and letter, and is arranging for return of all recalled products. Consumers/distributors/retailers that have these products which are being recalled should stop using and contact Bryant Ranch Prepack Inc. at: [email protected] or call 877-885-0882.

Consumers with questions regarding this recall can contact Bryant Ranch Prepack Inc. by 877-885-0882 or [email protected] , Monday-Friday 7:30am-5:00pm PDT. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

Complete and submit the report Online

Regular Mail or Fax: Download form or call 1- 800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

Reproduced from the company announcement posted on fda.gov. Links and contact forms in the original are not repeated here; the official notice below has them.

Check your product

The notice names 9 codes you can read straight off the package. Type the one printed on yours and the list below narrows to it.

Lot or batch code

Usually ink-stamped near the seam, the cap or the bottom of the pack.

  • 179642
  • 08/31/2023

Best-by / use-by date

Printed beside the lot code, not on the price sticker.

  • 11/30/2023

Establishment number

Inside the USDA mark of inspection on the label.

  • 71
  • 72

NDC number

On the carton and again on the bottle or blister label.

  • 63629-1088-01

Model or item number

On the rating label, the box or the instruction sheet.

  • 60

Package size

Match the net weight or the piece count on the front of the pack.

  • 30 mg
  • 60 mg

Codes are lifted verbatim from the FDA — Company recall announcements notice. A code that is missing here may still be covered — the official notice is the complete list.

What to do about Mislabelled

Bryant Ranch Prepack — Misbranding prompted this recall. The agency treats a label that misstates the contents as seriously as it treats contamination, because people act on labels.

  1. Read the official notice to see what is actually inside the pack, then decide whether anyone in your home needs to avoid it.
  2. Check the lot code on your pack — these mix-ups are usually confined to a short production window.
  3. If the undeclared contents include an allergen, treat it as an allergen recall and stop serving it to anyone affected.
  4. Return it for a refund; a mislabelled pack is returnable whether or not it is edible for your household.

Refunds, and what else you can claim

The purchase price is the floor, not the ceiling. Where a recall caused you a real cost, say so.

  • Claim the refund at the store first; it is the fastest route and needs the least paperwork.
  • If you bought several packs over time, list them. Firms routinely settle for more than a single unit when a customer asks.
  • Medical costs, lost earnings or a spoiled event are not handled at the service desk. Write to the company contact on this page instead, with dates and documents.
  • Keep copies of everything you send. If a recall caused harm, that file is what any later claim rests on.

Company contact: Bryant Ranch Prepack Inc. — Consumers: Bryant Ranch Prepack Inc., Shean Strong, (877) 885-0882, [email protected]

The official notice

This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.

Open the FDA — Company recall announcements record U.S. Food and Drug Administration recalls

Questions people ask about this recall

Why was Bryant Ranch Prepack prescription & otc drugs recalled?

Incorrect labeling Risk Statement: Patients prescribed the 30 mg dose who receive the 60 mg dose could be at risk for overdose and death.

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: lot code 179642, 08/31/2023; best-by date 11/30/2023; establishment number 71, 72; model number 60. If the code on your package is not on that list, your unit is outside the recall.

What should I do with it right now?

Read the official notice to see what is actually inside the pack, then decide whether anyone in your home needs to avoid it.

Can I get my money back?

Claim the refund at the store first; it is the fastest route and needs the least paperwork.

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